Drug · FAERS side-effect profile with label screen
Scopolamine side effects: what 5,642 FDA adverse event reports show
Who reports
5,642 reports · 68% serious · 746 with death outcome · 65% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Scopolamine transdermal system is indicated in adults for the prevention of: nausea and vomiting associated with motion sickness. post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery. Scopolamine transdermal system is an anticholinergic indicated in adults for the prevention of: nausea and vomiting associated with motion sickness.
FDA label, Indications and Usage
What it is
Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.5 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.0 2,4 ]nonan-7-yl) 3-hydroxy-2 phenylpropanoate.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 5Labeled (related wording) 11Reporting / coding artifact 5Lab value / disease marker 2Not in label — unassessed 17
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 467 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Mydriasis | 200 | 58.9 51.4–67.6ROR 61.0 · χ² 11,155 / p <1e-300 | 57.7 EB05 51.3 · IC025 +5.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 34.1 · ♀ 88% (drug 65%) | no trial data cached |
| Application site irritation | 72 | 21.6 17.2–27.2ROR 21.9 · χ² 1,389 / p <1e-300 | 21.4 EB05 17.6 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=12 · 82% consumer | no trial data cached |
| Application site rash | 67 | 18.1 14.3–23.0ROR 18.3 · χ² 1,063 / p 2e-233 | 18.0 EB05 14.6 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious n=11 · ♀ 88% (drug 65%) · 79% consumer | no trial data cached |
| Application site pruritus | 86 | 14.1 11.5–17.4ROR 14.3 · χ² 1,034 / p 4e-227 | 14.0 EB05 11.6 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious n=17 · 92% consumer | no trial data cached |
| Application site erythema | 98 | 13.9 11.4–16.9ROR 14.1 · χ² 1,157 / p 8e-254 | 13.8 EB05 11.6 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious n=23 · 85% consumer | no trial data cached |
| Salivary hypersecretion | 35 | 13.1 9.4–18.2ROR 13.1 · χ² 377 / p 3e-84 | 12.7 EB05 9.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.3 | no trial data cached |
| Product adhesion issue | 106 | 11.1 9.2–13.5ROR 11.3 · χ² 967 / p 1e-212 | 11.0 EB05 9.3 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious n=8 · 92% consumer | no trial data cached |
| Disorientation | 115 | 10.8 9.0–12.9ROR 11.0 · χ² 1,011 / p 4e-222 | 10.6 EB05 9.0 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.0 | no trial data cached |
| Aspiration | 29 | 10.0 6.9–14.3ROR 10.0 · χ² 225 / p 4e-51 | 9.2 EB05 6.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 · ♀ 20% (drug 65%) | no trial data cached |
| Dry mouth | 205 | 9.4 8.2–10.8ROR 9.7 · χ² 1,539 / p <1e-300 | 9.3 EB05 8.3 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 · 83% consumer | no trial data cached |
| Application site pain | 52 | 8.8 6.7–11.5ROR 8.9 · χ² 351 / p 1e-78 | 8.4 EB05 6.6 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious n=11 · 88% consumer | no trial data cached |
| Withdrawal syndrome | 99 | 8.7 7.2–10.6ROR 8.9 · χ² 670 / p 5e-148 | 8.5 EB05 7.2 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.8 · 89% consumer | no trial data cached |
| Hallucination (hallucinations) | 173 | 8.6 7.4–10.0ROR 8.8 · χ² 1,155 / p 2e-253 | 8.5 EB05 7.4 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 | no trial data cached |
| Supraventricular tachycardia | 20 | 7.8 5.0–12.1ROR 7.8 · χ² 111 / p 2e-26 | 6.8 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Drug ineffective for unapproved indication | 116 | 7.7 6.5–9.3ROR 7.9 · χ² 676 / p 3e-149 | 7.6 EB05 6.5 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 8.4 | no trial data cached |
| Vision blurred (blurred vision) | 278 | 7.6 6.8–8.5ROR 7.9 · χ² 1,588 / p <1e-300 | 7.5 EB05 6.8 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.8 · ♀ 86% (drug 65%) · 80% consumer | no trial data cached |
| Incorrect drug administration duration | 58 | 7.6 5.9–9.8ROR 7.6 · χ² 324 / p 1e-72 | 7.2 EB05 5.8 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 7.7 · 91% consumer | no trial data cached |
| Therapeutic response unexpected | 88 | 7.3 5.9–9.0ROR 7.4 · χ² 470 / p 1e-104 | 7.0 EB05 5.9 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 10.1 · 87% consumer | no trial data cached |
| Pneumonia aspiration | 47 | 7.0 5.3–9.3ROR 7.1 · χ² 237 / p 1e-53 | 6.6 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · ♀ 33% (drug 65%) | no trial data cached |
| Neutrophil count increased | 19 | 6.9 4.4–10.8ROR 6.9 · χ² 90 / p 1e-21 | 6.0 EB05 4.0 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 6.3 | no trial data cached |
| Vertigo (spinning dizziness) | 110 | 6.7 5.6–8.1ROR 6.8 · χ² 530 / p 1e-117 | 6.5 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 · 83% consumer | no trial data cached |
| Hiatus hernia | 23 | 6.6 4.4–9.9ROR 6.6 · χ² 104 / p 1e-24 | 5.9 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · ♀ 100% (drug 65%) | no trial data cached |
| Delirium | 61 | 6.6 5.1–8.4ROR 6.6 · χ² 282 / p 1e-63 | 6.3 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Dermatitis contact | 20 | 6.6 4.2–10.2ROR 6.6 · χ² 89 / p 2e-21 | 5.8 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=4 | no trial data cached |
| Impaired driving ability | 20 | 6.5 4.2–10.1ROR 6.6 · χ² 88 / p 3e-21 | 5.8 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Swollen tongue | 54 | 6.4 4.9–8.4ROR 6.5 · χ² 242 / p 7e-55 | 6.1 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 · ♀ 100% (drug 65%) | no trial data cached |
| Dry throat | 17 | 6.2 3.9–10.0ROR 6.2 · χ² 69 / p 4e-17 | 5.4 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Hallucination, visual | 35 | 6.2 4.5–8.6ROR 6.2 · χ² 148 / p 3e-34 | 5.8 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.4 | no trial data cached |
| Atelectasis | 16 | 6.1 3.8–10.0ROR 6.2 · χ² 64 / p 7e-16 | 5.3 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Hyperlipidaemia | 19 | 5.9 3.8–9.2ROR 5.9 · χ² 72 / p 9e-18 | 5.2 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Lymphocyte count decreased | 28 | 5.9 4.1–8.5ROR 5.9 · χ² 109 / p 9e-26 | 5.4 EB05 3.9 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 5.8 | no trial data cached |
| Acute respiratory failure | 30 | 5.8 4.1–8.3ROR 5.9 · χ² 115 / p 4e-27 | 5.4 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Metastases to central nervous system | 20 | 5.8 3.8–9.0ROR 5.8 · χ² 75 / p 3e-18 | 5.2 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.9 | no trial data cached |
| Ileus | 19 | 5.7 3.7–9.0ROR 5.8 · χ² 70 / p 3e-17 | 5.1 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Akathisia (inner restlessness) | 21 | 5.7 3.7–8.8ROR 5.7 · χ² 77 / p 8e-19 | 5.1 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Confusional state (confusion) | 240 | 5.5 4.9–6.2ROR 5.7 · χ² 889 / p 1e-195 | 5.5 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 | no trial data cached |
| Hypothermia | 15 | 5.5 3.3–9.1ROR 5.5 · χ² 51 / p 5e-13 | 4.8 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Small intestinal obstruction | 18 | 5.5 3.4–8.7ROR 5.5 · χ² 61 / p 3e-15 | 4.8 EB05 3.2 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 | no trial data cached |
| Photophobia (light sensitivity) | 27 | 5.4 3.7–7.8ROR 5.4 · χ² 92 / p 4e-22 | 4.9 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · ♀ 88% (drug 65%) · 100% consumer | no trial data cached |
| Device related infection | 22 | 5.3 3.5–8.1ROR 5.3 · χ² 73 / p 8e-18 | 4.8 EB05 3.3 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Nausea | 698 | 3.3 3.1–3.5ROR 3.6 · χ² 1,153 / p 4e-253 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.5 | no trial data cached |
| Off label use (used outside approved label) | 594 | 2.5 2.4–2.7ROR 2.7 · χ² 579 / p 3e-128 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 | no trial data cached |
| Vomiting | 490 | 3.9 3.6–4.2ROR 4.2 · χ² 1,071 / p 3e-235 | 3.9 EB05 3.6 · IC025 +1.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.7 | no trial data cached |
| Dizziness | 447 | 3.3 3.1–3.7ROR 3.5 · χ² 747 / p 7e-165 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 · 74% consumer | no trial data cached |
| Headache | 358 | 2.1 1.9–2.4ROR 2.2 · χ² 219 / p 8e-50 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
| Vision blurred (blurred vision) | 278 | 7.6 6.8–8.5ROR 7.9 · χ² 1,588 / p <1e-300 | 7.5 EB05 6.8 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.8 · ♀ 86% (drug 65%) · 80% consumer | no trial data cached |
| Malaise (feeling unwell) | 250 | 2.1 1.9–2.4ROR 2.2 · χ² 149 / p 2e-34 | 2.1 EB05 1.9 · IC025 +0.9 | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
| Death | 249 | 1.1 1.0–1.2ROR 1.1 · χ² 1 / p 0.130 | 1.1 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.9 | no trial data cached |
| Confusional state (confusion) | 240 | 5.5 4.9–6.2ROR 5.7 · χ² 889 / p 1e-195 | 5.5 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 | no trial data cached |
| Dry mouth | 205 | 9.4 8.2–10.8ROR 9.7 · χ² 1,539 / p <1e-300 | 9.3 EB05 8.3 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 · 83% consumer | no trial data cached |
| Mydriasis | 200 | 58.9 51.4–67.6ROR 61.0 · χ² 11,155 / p <1e-300 | 57.7 EB05 51.3 · IC025 +5.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 34.1 · ♀ 88% (drug 65%) | no trial data cached |
| Product quality issue | 180 | 5.0 4.3–5.7ROR 5.1 · χ² 570 / p 4e-126 | 4.9 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 · 80% consumer | no trial data cached |
| Anxiety | 179 | 2.3 2.0–2.7ROR 2.4 · χ² 137 / p 7e-32 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Product use in unapproved indication | 179 | 2.7 2.4–3.1ROR 2.8 · χ² 196 / p 8e-45 | 2.7 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 1.8 · 72% consumer | no trial data cached |
| Hallucination (hallucinations) | 173 | 8.6 7.4–10.0ROR 8.8 · χ² 1,155 / p 2e-253 | 8.5 EB05 7.4 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Salivary hypersecretion — n=35, PRR 13.1
- Aspiration — n=29, PRR 10.0
- Supraventricular tachycardia — n=20, PRR 7.8
- Pneumonia aspiration — n=47, PRR 7.0
- Hiatus hernia — n=23, PRR 6.6
- Delirium — n=61, PRR 6.6
- Dermatitis contact — n=20, PRR 6.6
- Impaired driving ability — n=20, PRR 6.5
- Swollen tongue — n=54, PRR 6.4
- Acute respiratory failure — n=30, PRR 5.8
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Scopolamine?
In FDA FAERS, the most frequently co-reported reaction terms for Scopolamine are nausea, vomiting, dizziness, headache, vision blurred, malaise. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Scopolamine have an FDA boxed warning?
No. The FDA label retrieved for Scopolamine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Scopolamine causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 2a6f9aaf-a70a-481f-a82b-1dcaaadc185b, effective 20260909; matched on
openfda.generic_name.exact:"SCOPOLAMINE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 507 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.